India allows local company to import Moderna COVID-19 vaccine for emergency use
The Drugs Controller General of India (DCGI) Tuesday allowed Mumbai-based multinational pharmaceutical company Cipla to import Moderna COVID-19 vaccine for restricted emergency use in India, officials said.
V K Paul, member (health) of government think-tank National Institution for Transforming India (NITI ) Aayog (commission) confirmed the development during a media briefing in New Delhi.
“This opens up the likelihood of the vaccine being imported in near future. This is the fourth vaccine,” he said, adding, “This is only the regulatory approval given. Indemnity issue is being examined.”
Paul said there will be no need for bridging studies for this vaccine.
“No, there will be no need for bridging studies that have been already clarified. This modification in our regulation happened several weeks ago, so they won’t be asked to carry out bridging trials. People who would get the first 100 doses will be watched out,” Paul said. “The way has been cleared for the import of this vaccine (Moderna) into the country.”
Moderna’s vaccine will be the fourth COVID-19 vaccine to be available in India after Covishield, Covaxin and Sputnik.